BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2991791 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-02953
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 24, 2011
    Report Date
    January 10, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: SINCE SURGICAL IMPLANTATION OF THE ASR XL ACETABULAR SYSTEMS, PATIENT HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SORENESS AND DIFFICULTY WALKING. PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY AND CONSCIOUS PAIN AND SUFFERING. PATIENT WAS REQUIRED TO UNDERGO REVISION SURGERY ON HIS RIGHT AND LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96276 ASR UNI FEMORAL IMPL SIZE 47 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2345763

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention